Software Quality Engineer

Job Description

We are seeking a dedicated Software Quality Engineer to join our team, focusing on ensuring the high standards of software quality in an electromechanical and controls environment, particularly within the medical device sector.

Responsibilities

• Ensure software quality in an electromechanical/controls environment, with a focus on robotics.
• Utilize medical device experience to support software quality processes.
• Conduct SWFMEA and risk analysis to enhance software reliability.
• Participate in new product introduction and development processes (NPI/NPD).
• Support the development of compliant medical device software or SaMD, adhering to IEC standards.
• Collaborate effectively within a technical environment to meet project deadlines.
• Contribute as a team player in achieving collective goals.

Essential Skills

• Minimum of 8 to 10 years of experience as a Software Quality or Software Design Quality Engineer in the medical device industry.
• Bachelor's degree in Engineering, Computer Engineering, or Software Engineering.
• Experience with new product development in the medical device sector.
• Working knowledge of Software Medical regulation, IEC-62304 is required, IEC 80601
• Experience in SWFMEA development.
• Strong organizational and detail-oriented skills.

Additional Skills & Qualifications

• Knowledge of IEC software medical regulation and IEC medical robotics.
• Robotics quality experience and safety standards.
• Experience in software controls quality and failure modes.

Work Environment

The role requires working onsite for three days a week in Newton, MA, with flexibility based on test cycles. The environment is fast-paced, requiring adaptability to changing deadlines.